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Manufacturer
UNILAB, Inc.
Distributor
UNILAB, Inc.
Contents
Per Neozep Forte tab Phenylephrine HCl 10 mg, chlorphenamine maleate 2 mg,
paracetamol 500 mg. Per Neozep Non-Drowsy tab Phenylephrine HCl 10 mg,
paracetamol 500 mg
Indications / Uses
Relief of clogged nose, post nasal drip, headache, body aches & fever associated w/
common cold, sinusitis, flu & other minor resp tract infections; decongest sinus
openings & passages. Neozep Forte Itchy & watery eyes, sneezing, allergic rhinitis.
Neozep Forte: These medicines are used for the relief of clogged nose, runny nose, postnasal
drip, itchy and watery eyes, sneezing, headache, body aches, and fever associated with the
common cold, allergic rhinitis, sinusitis, flu, and other minor respiratory tract infections. They
also help decongest sinus openings and passages.
Neozep Non-Drowsy: This medicine is used for the relief of clogged nose, postnasal drip,
headache, body aches, and fever associated with the common cold, sinusitis, flu, and other
minor respiratory tract infections. It also helps decongest sinus openings and passages.
Contraindications
If the patient is allergic to any ingredient in the product.
If the patient has high blood pressure or severe heart disease unless recommended by a doctor.
If the patient has anemia, kidney or liver disease unless recommended by a doctor.
If the patient is pregnant or breastfeeding.
Adverse Reactions
Phenylephrine HCl may cause tremor (muscle shaking), restlessness, anxiety (feeling of
uneasiness), insomnia/sleeplessness, nervousness, dizziness, increased blood
pressure, palpitation, arrhythmia (irregular heart beat), weakness, respiratory distress
(noisy, congested breathing), and pallor.
Paracetamol, when taken within the recommended dose and duration of treatment, has
low incidence of side effects. Skin rashes, hypersensitivity reactions, changes in the
number of white blood cells and platelets, and minor stomach and intestinal
disturbances have been reported.
Neozep Forte: Chlorphenamine Maleate may cause sleepiness and drowsiness. Other
undesirable effects include muscle weakness, gastrointestinal discomfort, nausea,
vomiting, diarrhea or constipation, dryness of the mouth, nose, and throat, difficulty
urinating, ringing in the ears, visual disturbance, blurred vision, insomnia/sleeplessness,
tremor, nervousness, irritability, chest tightness, increased or decreased blood
pressure, and headache.
Mechanism of Action
Phenylephrine HCl, a nasal decongestant, clears obstructed air passages and nasal
sinuses due to congestion making breathing easier.
It also reduces postnasal drip.
Paracetamol is an effective fever reducer and pain reliever.
Neozep Forte: These medicines contain Phenylephrine HCl, Chlorphenamine Maleate
and Paracetamol.
Chlorphenamine Maleate, an anti-allergy, relieves symptoms such as runny nose,
sneezing, and itchy, watery eyes.
Neozep Non-Drowsy: This medicine contains Phenylephrine HCl and Paracetamol.
Dosage
Neozep Forte: These medicines should be taken orally (by mouth).
Neozep Non-Drowsy: Adults and Children 12 years and older: Orally, 1 tablet every 6 hours,
Missed dose: If the patient missed a dose, just take the next dose if still needed for the
condition being treated, and the subsequent doses at the recommended time or schedule (i.e.,
every 6 hours).
Overdosage
skin); Cerebral hemorrhage (bleeding from a ruptured blood vessel in the brain); Seizures.
Paracetamol: Overdosage of Paracetamol usually involves 4 phases with the following signs
and symptoms: I. Eating disorder, nausea, vomiting, malaise, and excessive sweating.
II. Right upper abdominal pain or tenderness, liver enlargement which may be characterized by
abdominal discomfort of "feeling full", elevated bilirubin and liver enzyme concentrations,
III. Eating disorder, nausea, vomiting, and malaise recur and signs of liver (e.g., jaundice) and
If the patient has taken more than the recommended dosage, consult a doctor or contact a
poison control center right away, even if the patient seems well, because of the risk of delayed,
serious liver damage. Quick medical attention is important for adults as well as for children even
Drug Interactions
Do not use this product together with sympathomimetic agents (e.g., Epinephrine, etc.)
and general anesthetics (e.g., Halothane, etc.) because of the possibility for increased
toxicity.
Concurrent administration with medicines for depression (e.g., Amitriptyline, Imipramine,
Sertraline, Moclobemide, etc.) may result in hypertensive crisis (sudden, severe
increase in blood pressure that can lead to stroke).
Taking an adrenergic-blocking agent (e.g., Phenothiazine drugs, Phentolamine,
Propranolol, etc.) before the administration of this product may decrease the effect of
Phenylephrine.
Medicines which stimulate the enzymes responsible for the metabolic activation of
Paracetamol such as medicines for convulsion (e.g., Phenobarbital, etc.) may increase
susceptibility to the harmful effects to the liver.
Warfarin, a blood thinning medicine; an increase in the International Normalized Ratio
(INR), which may serve as a sign of increased risk for bleeding, may be observed when
using Paracetamol and Warfarin at the same time. Paracetamol increases the
anticoagulation effect of Warfarin.
Tell the doctor about other medicines the patient is taking, especially other medicines
for cough, cold, allergy, pain, or fever.
Neozep Forte: The absorption of Paracetamol may be accelerated by metoclopramide
or domperidone and absorption reduced by cholestyramine.
Presentation / Storage
Description
Neozep Forte: Tab (green and white, elliptical-convex, 0.662" x 0.300" in diameter,
two-layer tablet, debossed with "NEOZEP" on the green layer, and plain on the white
layer) 4's, 500's.
Neozep Non-Drowsy: Tab (green, 0.662" x 0.300" elliptical-shaped plain tablet,
debossed with "NEOZEP" on one side and plain on the other side) 4's, 100's.
Storage
Biogesic
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but
there are no controlled studies in pregnant women or animal-reproduction studies have
shown an adverse effect (other than a decrease in fertility) that was not confirmed in
controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later
trimesters).
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve
pain and fever.
Regulatory Classification
Non-Rx
Presentation / Packing
Form Photo Packing/Price
Biogesic oral drops 100 (orange flavor) 15 mL x 1's
mg/mL (P50.25/bottle)
Biogesic oral susp 120 mg/5 (orange & strawberry flavor) 60 mL x
mL 1's (P61.22/bottle)
Biogesic oral susp 250 mg/5
60 mL x 1's (P87.28/bottle)
mL
20's (P3.25/pack)
Biogesic tab 500 mg
500's (P1625.00/pack)
Tempra
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but
there are no controlled studies in pregnant women or animal-reproduction studies have
shown an adverse effect (other than a decrease in fertility) that was not confirmed in
controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later
trimesters).
MIMS Class
Analgesics (Non-Opioid) & Antipyretics
ATC Classification
N02BE01 - paracetamol ; Belongs to the class of anilide preparations. Used to relieve
pain and fever.
Regulatory Classification
Non-Rx
Presentation / Packing
Form Photo Packing/Price
100's (P385.05/pack)
Tempra tab 325 mg
500's (P1925.00/pack)
Solmux
Dosage Adult : PO Initial: 2.25 g/day in divided doses, then 1.5 g/day in divided doses as condition
improves.
Adult: Initially, 2.25 g daily in divided doses, then 1.5 g daily in divided doses as condition
improves.
Child: 2-5 yr 62.5-125 mg 4 times daily; 6-12 yr 250 mg tid.
Adverse Drug Nausea, gastric discomfort, GI bleeding, skin rash, Stevens-Johnson syndrome, erythema
Reactions multiforme.
Mechanism of Description: Carbocisteine reduces goblet cell hyperplasia and therefore plays a role in the
Action management of disorders characterised by abnormal mucous.
Pharmacokinetics:
Absorption: Rapidly and well absorbed from the GI tract. Time to peak plasma
concentration: Approx 2 hr.
Distribution: Penetrates into lung tissue and resp mucous.
Metabolism: Undergoes acetylation, decarboxylation and sulfoxidation.
Excretion: Via urine as unchanged drug and metabolites.
Medicol
Basic Prescribing Info
Contents
Ibuprofen
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AE01 - ibuprofen ; Belongs to the class of propionic acid derivatives of non-
steroidal antiinflammatory and antirheumatic products.
Indications Listed in Dosage.
Dosage Adult : PO Rheumatoid arthritis; Osteoarthritis 400-800 mg 3-4 times/day. Max: 3.2
g/day. Mild to moderate pain; Dysmenorrhoea; Fever 200-400 mg 4-6 hrly. Max: 2.4
g/day. IV Pain relief 400-800 mg 6 hrly, as needed. Max: 3.2 g/day. Fever Initially, 400 mg
followed by 400 mg 4-6 hrly, or 100-200 mg 4 hrly. Max: 3.2 g/day. Topical/Cutaneous Pain
and inflammation associated w/ musculoskeletal and joint disorders As 5% cream,
foam, gel, spray soln or 10% gel: Apply as directed.
Dosage Details Intravenous
Closure of patent ductus arteriosus
Child: Given as 3 IV doses infused over 15 min at 24-hr intervals. Initially 10 mg/kg
followed by 2 doses of 5 mg/kg. A 2nd course may be given if ductus remains open after 48
hr. Dose should be based on birth wt.
Intravenous
Pain relief
Intravenous
Fever
Adult: Initially, 400 mg followed by 400 mg 4-6 hrly, or 100-200 mg 4 hrly. Max: 3.2 g daily.
Oral
Juvenile rheumatoid arthritis
Oral
Fever
Adult: 200-400 mg 4-6 hrly. Max: 1.2 g daily (under doctor’s supervision, 2.4 g/day).
Child: 6 mth to 12 yr 10 mg/kg 6-8 hrly. Max: 40 mg/kg/day.
Oral
Mild to moderate pain
Adult: 200-400 mg 4-6 hrly. Max: 1.2 g daily (under doctor’s supervision, 2.4 g/day).
Child: 4-10 mg/kg/day 6-8 hrly.
Oral
Osteoarthritis, Rheumatoid arthritis
Oral
Dysmenorrhoea
Adult: 200-400 mg 4-6 hrly. Max: 1.2 g daily (under doctor’s supervision, 2.4 g/day).
Topical/Cutaneous
Pain and inflammation associated with musculoskeletal and joint disorders
Adult: As 5% cream, foam, gel, spray soln or 10% gel: Apply onto affected area.
Administration Should be taken with food.
Contraindications Hypersensitivity. Treatment of perioperative pain in the setting of CABG surgery. Patient
whom asthma, urticaria or other allergic-type reaction are precipitated by aspirin or other
NSAIDs. Active or history of peptic ulcer; history of GI bleeding. Neonates w/ congenital
heart disease, suspected necrotising enterocolitis, and impaired renal function. 3rd trimester
of pregnancy, and lactation.
Special Precautions Bleeding disorders, CV disease. Infants w/ increased total bilirubin. Premature neonates w/
existing or at risk of infection. Hepatic and renal impairment. Elderly (avoid chronic use).
Adverse Drug Oral: Dizziness, headache, nervousness, epigastric pain, heartburn, nausea, abdominal
Reactions pain, decreased appetite, constipation, diarrhoea, dyspepsia, flatulence, vomiting, oedema,
itching, rash, fluid retention, tinnitus. IV: HTN, intraventricular haemorrhage, pulmonary
haemorrhage, skin irritation, pruritus, hypocalcaemia, hypoglycaemia, GI disorders,
anaemia, apnoea, resp infection, cough, sepsis, fluid retention, haematuria, necrotising
enterocolitis, adrenal insufficiency, hypernatraemia, increased BUN, UTI.
Potentially Fatal: Severe CV thrombotic events, MI, stroke, severe GI bleeding, ulceration
and perforation. Severe hepatic reactions (e.g. jaundice and hepatitis).
Drug Interactions Increased risk of GI bleeding w/ warfarin, corticosteroids, SSRIs and aspirin. May reduce
the natriuretic effects of diuretics. Reduced antihypertensive effect of ACE inhibitors and
angiotensin II receptor antagonists. May increase toxicity of lithium and methotrexate.
Increased nephrotoxicity w/ ciclosporin and tacrolimus.
Alaxan
Basic Prescribing Info
Contents
Paracetamol 325 mg, ibuprofen 200 mg
MIMS Class
Analgesics (Non-Opioid) & Antipyretics / Nonsteroidal Anti-Inflammatory Drugs
(NSAIDs)
ATC Classification
M01AE51 - ibuprofen, combinations ; Belongs to the class of propionic acid derivatives
of non-steroidal antiinflammatory and antirheumatic products.
Cortal Pain
Dolfenal 250
Contraindications Hypersensitivity to mefenamic acid, aspirin or other NSAIDs. Patient w/ inflammatory bowel
disease, active ulceration or chronic inflammation of the upper or lower GI tract, renal
failure. History of asthma, urticaria, allergic-type reactions. Treatment of perioperative pain
in the setting of CABG surgery.
Special Precautions Patient w/ known CV disease or risk factors for CV disease, history of GI bleeding or peptic
ulceration, fluid retention or heart failure. Renal and hepatic impairment. Pregnancy and
lactation.
Adverse Drug CHF, HTN, tachycardia, syncope, arrhythmia, vasculitis, hypotension, palpitations;
Reactions abdominal pain, vomiting, dyspepsia, constipation, diarrhoea, nausea, heartburn, GI
perforation, peptic ulcer, flatulence; decrease in haematocrit, thrombocytopenia, haemolytic
anaemia, aplastic anaemia, agranulocytosis, leucopenia, eosinophilia; headache, dizziness,
nervousness, drowsiness, insomnia, nervousness, anxiety, confusion, tremors, vertigo;
blurred vision, conjunctivitis, tinnitus, hearing impairment; abnormal renal function, oedema,
proteinuria, cystitis; elevated LFTs, urticaria, rash, pruritus, alopecia, perspiration,
photosensitivity, resp depression, pneumonia, fever, infection.
Potentially Fatal: Anaphylactoid reactions, Stevens-Johnson syndrome, toxic epidermal
necrolysis, exfoliative dermatitis, MI, stroke, GI bleeding, jaundice and fulminant hepatitis,
liver necrosis, and hepatic failure, renal toxicity.
Monitoring Monitor CBC, chemistry profile, hepatic and renal function during long-term therapy. BP
Parameters should be monitored closely during initiation and throughout therapy.
Overdosage Symptoms: Headache, nausea, vomiting, epigastric pain, GI bleeding. Rarely, diarrhoea,
disorientation, excitation, coma, drowsiness, tinnitus, fainting, and occasionally convulsions.
Management: Symptomatic and supportive treatment. In acute overdosage, empty the
stomach immediately by inducing emesis or by gastric lavage followed by admin of
activated charcoal.
Drug Interactions Concomitant use w/ CYP2C9 isoenzyme inhibitors may alter safety and efficacy of
mefenamic acid. May enhance methotrexate toxicity. Reduced BP response to ACE
inhibitors or angiotensin II receptor antagonists. Increased risk of serious GI events w/
aspirin. May reduce the natriuretic effects of furosemide or thiazide diuretics. Reduced renal
lithium clearance and elevated plasma lithium levels. May enhance anticoagulant effect of
warfarin.
Lab Interference May cause a false-positive reaction for urinary bile using the diazo test.
Ponstan 250
Mechanism of Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Mefenamic acid is a
nonsteroidal agent with demonstrated anti-inflammatory, analgesic and antipyretic
activity in laboratory animals. Mefenamic acid was found to inhibit prostaglandin
synthesis and to compete for binding at the prostaglandin receptor sites in animal
models.
Pharmacokinetics: Absorption: Mefenamic acid is rapidly absorbed from the
gastrointestinal tract. Following administration of a 1 g oral dose to adults, peak plasma
levels of 10 mcg/mL occur in 1-4 hrs, with a half-life of 2 hrs. Plasma levels are
proportional to dose, following multiple doses, with no drug accumulation.
One gram of mefenamic acid administered 4 times daily produces peak blood levels of
20 mcg/mL by the 2nd day of administration.
Distribution: Mefenamic acid is extensively bound to plasma proteins.
Metabolism: Mefenamic acid metabolism is predominantly mediated via cytochrome P-
450 CYP 2C9 in the liver.
Patients who are known or suspected to be poor CYP2C9 metabolizers based on
previous history/experience with other CYP2C9 substrates should be administered
mefenamic acid with caution as they may have abnormally high plasma levels due to
reduced metabolic clearance.
Elimination: Following a single oral dose, 52-67% of the dose was recovered from the
urine as unchanged drug or 1 of 2 metabolites. Assay of stools over 3 days accounted
for 20-25% of the dose, chiefly as unconjugated metabolite II.
Toxicology: Preclinical Safety Data: Rats given up to 10 times the human dose showed
decreased fertility, delay in parturition and a decreased rate of survival to weaning. No
fetal abnormalities were observed in this study and in another study in dogs receiving
10 times the human dose.
MIMS Class
Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
ATC Classification
M01AG01 - mefenamic acid ; Belongs to the class of non-steroidal antiinflammatory and
antirheumatic products, fenamates.
Regulatory Classification
250 mg SF cap:Non-Rx;500 mg SF cap/Tab/Susp:Rx
Presentation / Packing
Form Photo Packing/Price
Ponstan SF cap 250
200's (P3177.38/pack)
mg
60 mL x 1's (P163.03/box)
Ponstan oral susp
60 mL x 6 × 1's
50 mg/5 mL (P978.19/box)
Dosage Adult : PO 0.5-1 g 4-6 hrly. Max: 4 g/day. Rectal As supp: 0.5-1 g 4-6 hrly. Max: 4
g/day. IV 33-50 kg: 15 mg/kg as a single dose, at least 4 hrly. Max: 60 mg/kg/day up to 3
g/day; >50 kg: 1 g as a single dose, at least 4 hrly. Max: 4 g/day. Admin by infusion over 15
min.
Adult: 33-50 kg: 15 mg/kg as a single dose, at least 4 hrly. Max: 60 mg/kg (up to 3 g) daily;
>50 kg: 1 g as a single dose, at least 4 hrly. Max: 4 g daily. Admin by infusion over 15 min.
Child: <10 kg: 7.5 mg/kg as a single dose, at least 4 hrly. Max: 30 mg/kg daily; 10-33 kg: 15
mg/kg as a single dose, at least 4 hrly. Max: 60 mg/kg (up to 2 g) daily; >33-50 kg: 15
mg/kg as a single dose, at least 4 hrly. Max: 60 mg/kg (up to 3 g) daily. Admin by infusion
over 15 min.
Oral
Mild to moderate pain and fever
Oral
Post-immunisation pyrexia
Child: 2-3 mth 60 mg. If necessary, a 2nd dose may be given after 4-6 hr.
Rectal
Mild to moderate pain and fever
Rectal
Post-immunisation pyrexia
Child: 2-3 mth 60 mg. If necessary, a 2nd dose may be given after 4-6 hr.
CrCl
Dosage
(mL/min)
Reconstitution Intravenous:
Dilute soln to a minimum strength of 1 mg/mL in NaCl 0.9% or glucose 5%; diluted soln
should be used w/in 1 hr of preparation.
Special Precautions Patient w/ chronic alcoholism, known G6PD deficiency, severe hypovolaemia, chronic
malnutrition. Renal and hepatic impairment. Pregnancy and lactation.
Overdosage Symptoms: Pallor, nausea, vomiting, abdominal pain, anorexia, CNS stimulation,
excitement, delirium, metabolic acidosis, glucose metabolism abnormalities. In severe
poisoning, liver damage may lead to encephalopathy, haemorrhage, hypoglycaemia,
cerebral oedema and death. Management: Admin activated charcoal if taken w/in 1 hr and
>150 mg/kg has been ingested. Determine plasma paracetamol concentration at 4 hr or
later after ingestion. Treatment w/ N-acetylcysteine may be used up to 24 hr after ingestion
(most effective if given w/in 8 hr). If needed, admin IV N-acetylcysteine. Oral methionine
may be a suitable alternative for remote areas if vomiting is not a problem.
Drug Interactions May reduce serum levels w/ anticonvulsants (e.g. phenytoin, barbiturates, carbamazepine).
May enhance the anticoagulant effect of warfarin and other coumarins w/ prolonged use.
Accelerated absorption w/ metoclopramide and domperidone. May increase serum levels w/
probenecid. May increase serum levels of chloramphenicol. May reduce absorption w/
colestyramine w/in 1 hr of admin. May cause severe hypothermia w/ phenothiazine.
Lab Interference May produce false-positive test results for urinary 5-hydroxyindoleacetic acid.
Mechanism of Description: Paracetamol exhibits analgesic action by peripheral blockage of pain impulse
Action generation. It produces antipyresis by inhibiting the hypothalamic heat-regulating centre. Its
weak anti-inflammatory activity is related to inhibition of prostaglandin synthesis in the CNS.
Synonym: acetaminophen.
Onset: Oral: <1 hr. IV: 5-10 min (analgesia); w/in 30 min (antipyretic).
Duration: 4-6 hr (analgesia). IV: ≥6 hr (antipyretic).
Pharmacokinetics:
Absorption: Readily absorbed from the GI tract. Time to peak plasma concentration:
Approx 10-60 min (oral).
Distribution: Distributed into most body tissues; crosses the placenta and enters breast
milk. Plasma protein binding: Approx 25%.
Metabolism: Hepatic via glucuronic and sulfuric acid conjugation. N-acetyl-p-
benzoquinoneimine (minor hydroxylated metabolite), is usually produced in very small
amounts by CYP2E1 and CYP3A4 isoenzymes in the liver and kidneys.
Excretion: Mainly via urine (as glucuronide and sulfate conjugates, <5% as unchanged
drug). Elimination half-life: Approx 1-3 hr.
Ambroxol
Indications As a mucolytic.
Loperamide
Indications Listed in Dosage.
Dosage Adult : PO Acute diarrhoea Initial: 4 mg, then 2 mg after each loose stool. Max: 16
mg/day. Chronic diarrhoea Initial: 4-8 mg/day in divided doses. Max: 16 mg/day.
Adult: Initially, 4 mg followed by 2 mg after each loose stool. Max: 16 mg daily. Discontinue
if clinical improvement is not observed w/in 48 hr.
Child: 4-8 yr 1 mg 3-4 times daily for up to 3 days; 9-12 yr 2 mg 4 times daily for up to 5
days.
Oral
Chronic diarrhoea
Adult: Initially, 4-8 mg daily in divided doses, adjusted if necessary. Max: 16 mg daily;
discontinue if no improvement at this dose after 10 days.
Special Precautions Not intended for use as a primary treatment in acute dysentery. Hepatic impairment. Childn.
Pregnancy and lactation.
Adverse Drug Abdominal pain or bloating, nausea and vomiting, constipation, dry mouth, drowsiness,
Reactions dizziness, fatigue, epigastric pain, hypersensitivity reactions (e.g. rash).
Potentially Fatal: Paralytic ileus (particularly in infants and young childn).
Category C: Either studies in animals have revealed adverse effects on the foetus
(teratogenic or embryocidal or other) and there are no controlled studies in women or
studies in women and animals are not available. Drugs should be given only if the potential
benefit justifies the potential risk to the foetus.
Patient Counselling This drug may cause drowsiness or dizziness, if affected it may impair ability to drive or
operate machinery.
Monitoring Monitor for signs of CNS toxicity (in patients w/ hepatic impairment).
Parameters
Overdosage Symptoms: CNS depression; constipation, urinary retention and ileus may occur.
Management: Employ gastric lavage followed by admin of activated charcoal. Naloxone HCl
may be given as antidote.
Drug Interactions Increased plasma levels w/ P-glycoprotein inhibitors (e.g. quinidine, ritonavir). May
decrease exposure to saquinavir.
Mechanism of Description: Loperamide reduces propulsive peristalsis and increases intestinal transit by
Action binding to the opiate receptor in the gut wall. It also increases the tone of the anal sphincter,
thereby reducing incontinence and urgency.
Pharmacokinetics:
Absorption: Approx 40% is absorbed from the GI tract. Time to peak plasma
concentration: 2.5 hr (oral soln); 5 hr (cap).
Metabolism: Hepatically converted to desmethylloperamide via N-demethylation by
CYP2C8 and CYP3A4 isoenzymes, CYP2B6 and CYP2D6 also play a role.
Excretion: Via faeces (as inactive conjugate); urine. Elimination half-life: Approx 10 hr.
ATC Classification A07DA03 - loperamide ; Belongs to the class of antipropulsives. Used in the treatment of
diarrhea.
HNBB
Indications / Uses
Acute gastrointestinal, biliary and genitourinary spasm, including biliary and renal colic.
As an aid in diagnostic and therapeutic procedures, where spasm may be a problem eg,
gastroduodenal endoscopy, and in radiology.
Special Precautions
Contraindications
Special Precautions
Adverse Reactions
Many of the listed adverse effects can be assigned to the anticholinergic properties of
Buscopan. Anticholinergic adverse effects of Buscopan are generally mild and self-
limited.
Immune System Disorders: Anaphylactic shock/reactions, dyspnea, skin reactions (eg,
urticaria, rash, erythema and pruritus) and other hypersensitivity reactions.
Eye Disorders: Accommodation disorders, mydriasis, increased intraocular pressure.
Cardiac Disorders: Tachycardia.
Vascular Disorders: Decreased blood pressure, dizziness, flushing.
Gastrointestinal Disorders: Dry mouth.
Skin and Subcutaneous Tissue Disorders: Dyshidrosis.
Renal and Urinary Disorders: Urinary retention.
Mechanism of Action
Pharmacology: Pharmacodynamics: The active ingredient in Buscopan is hyoscine-
N-butylbromide, a known antispasmodic substance. It relieves the pain by acting on the
muscle spasm which causes the pain. Buscopan exerts a spasmolytic action on the
smooth muscle of the gastrointestinal, biliary and genitourinary tracts. As a quaternary
ammonium derivative, hyoscine-N-butylbromide does not enter the central nervous
system. Therefore, anticholinergic side effects at the central nervous system do not
occur. Peripheral anticholinergic action results from a ganglion-blocking action within
the visceral wall as well as from an anti-muscarinic activity.
Pharmacokinetics: Absorption and Distribution: After IV administration, hyoscine-N-
butylbromide is rapidly distributed [α-phase elimination half-life (t½α)=4 min, β-phase
elimination half-life (t½β)=29 min] into the tissues. The volume of distribution (Vss) is 128
L (approximately 1.7 L/kg). Because of its high affinity for muscarinic receptors and
nicotinic receptors, hyoscine-N-butylbromide is mainly distributed on muscle cells of the
abdominal and pelvic area as well as in the intramural ganglia of the abdominal organs.
Plasma protein-binding (albumin) of hyoscine-N-butylbromide is approximately 4.4%.
Animal studies demonstrate that hyoscine-N-butylbromide does not pass the blood-
brain barrier, but no clinical data to this effect is available. Hyoscine-N-butylbromide (1
mM) has been observed to interact with the choline transport (1.4 nM) in epithelial cells
of human placenta in vitro.
Metabolism and Elimination: The main metabolic pathway is the hydrolytic cleavage of
the ester bond. The half-life of the terminal elimination phase (t½γ) is approximately 5
hrs. The total clearance is 1.2 L/min. Clinical studies with radiolabeled hyoscine-N-
butylbromide show that after IV injection, 42-61% of the radioactive dose is excreted
renally and 28.3-37% fecally.
The portion of unchanged active ingredient excreted in the urine is approximately 50%.
The metabolites excreted via the renal route bind poorly to the muscarinic receptors and
are therefore not considered to contribute to the effect of the hyoscine-N-butylbromide.
Toxicology: Preclinical Safety Data: Acutely, hyoscine-N-butylbromide has a low index
of toxicity: Oral mean lethal dose (LD50) values were 1,000-3,000 mg/kg in mice, 1,040-
3,300 mg/kg in rats, and 600 mg/kg in dogs. Toxic signs were ataxia and decreased
muscle tone, additionally, in mice tremor and convulsions, in dogs mydriasis, dry
mucous membranes and tachycardia. Deaths from respiratory arrest occurred within 24
hrs. The IV LD50 values of hyoscine-N-butylbromide were 10-23 mg/kg in mice and 18
mg/kg in rats.
In repeated oral dose toxicity studies over 4 weeks, rats tolerated 500 mg/kg=no
observed adverse effect level (NOAEL). At 2000 mg/kg, by the action on
parasympathetic ganglia of visceral area, hyoscine-N-butylbromide paralyzed the
gastrointestinal function resulting in obstipation. Eleven (11) out of 50 rats died.
Hematology and clinical chemistry results did not show dose-related variations.
Over 26 weeks, rats tolerated 200 mg/kg, while at 250 and 1,000 mg/kg, the
gastrointestinal function was depressed and deaths occurred. The NOAEL of the 39-
week oral (capsule) dog study was 30 mg/kg. The majority of clinical findings was
attributable to acute effects of hyoscine-N-butylbromide at high dosages (200 mg/kg).
No adverse histopathological findings were observed.
A repeated IV dose of 1 mg/kg was well-tolerated by rats in a 4-week study. At 3 mg/kg,
convulsions occurred immediately after injection. Rats dosed with 9 mg/kg died from
respiratory paralysis.
Dogs treated IV over 5 weeks at 2x1, 2x3 and 2x9 mg/kg, showed a dose-dependent
mydriasis in all treated animals. In addition, at 2x9 mg/kg, ataxia, salivation and
decreased body weight and food intake were observed. The solutions were locally well-
tolerated.
After repeated IM injection, the dose of 10 mg/kg was systemically well-tolerated, but
lesions of muscles at the site of injection were distinctly increased if compared to control
rats. At 60 and 120 mg/kg, mortality was high and local damages were dose-
dependently increased.
In special studies concerning local tolerability, a repeated IM injection of 15 mg/kg
Buscopan over 28 days was studied in dogs and monkeys. Small focal necroses at the
site of injection were seen only in dogs. Buscopan was well tolerated in arteries and
veins of the rabbit's ear. In vitro, Buscopan 2% injectable solution showed no hemolytic
action when mixed with 0.1 mL human blood.
Teratogenicity: Hyoscine-N-butylbromide was neither embryotoxic nor teratogenic at
oral doses of up to 200 mg/kg in the diet (rat) and 200 mg/kg by gavage or 50 mg/kg SC
(rabbit). Fertility was not impaired at doses of up to 200 mg/kg orally.
Like other cationic drugs, hyoscine-N-butylbromide interacts with the choline transport
system of human placental epithelial cells in vitro. Transfer of hyoscine-N-butylbromide
to the fetal compartment has not been proved.
Mutagenicity: Hyoscine-N-butylbromide revealed no mutagenic or clastogenic potential
in the Ames test, in the in vitro gene mutation assay in mammalian V79 cells
[hypoxanthine-guanine phosphoribosyltransferase (HPRT) test] and in an in
vitro chromosome aberration test in human peripheral lymphocytes. In vivo, hyoscine-N-
butylbromide was negative in the rat bone marrow micronucleus assay.
Carcinogenicity: There are no in vivo carcinogenicity studies. Nevertheless, hyoscine-N-
butylbromide did not show a tumorigenic potential in 2 oral 26-week-studies in rats
given up to 1,000 mg/kg.
Dosage
Overdosage
Tablet: Adults and Children >6 years: 1-2 tablets 3-5 times daily.
Injection: Adults and Adolescents >12 years: 1-2 ampoules (20-40 mg). Maximum
Daily Dose: 100 mg should not be exceeded.
Children and Infants: Severe Cases: 0.3-0.6 mg/kg body weight. Maximum Daily
Dose: 1.5 mg/kg body weight should not be exceeded.
Administration: Tablet: The tablet should be swallowed whole with adequate fluid.
Injection: Administer by slow IV, IM or SC injection several times daily.
Buscopan should not be taken on a continuous daily basis or for extended periods
without investigating the cause of abdominal pain.
Overdosage
Symptoms: In case of overdosage, anticholinergic effects may be observed.
Treatment: If required, parasympathomimetic drugs should be administered.
Ophthalmological advice should be sought in cases of glaucoma urgently.
Cardiovascular complications should be treated according to usual therapeutic
principles. In case of respiratory paralysis: Intubation, artificial respiration should be
considered.
Catheterization may be required for urinary retention. In addition, appropriate supportive
measures should be used as required.
Drug Interactions
Inform physician if taking any other medicine while taking Buscopan. The anticholinergic
effect of drugs eg, tri- and tetracylic antidepressants, antihistamines, antipsychotics,
quinidine, amantadine, disopyramide and other anticholinergics (eg, tiotropium,
ipratropium, atropine-like compounds) may be intensified by Buscopan.
Concomitant treatment with dopamine antagonists eg, metoclopramide may result in
diminution of the effects of both drugs on the gastrointestinal tract.
The tachycardic effects of β-adrenergic agents may be enhanced by Buscopan.
Presentation / Storage
Description
Kremil-s
Bromhexine
Indications As a mucolytic.
Adult: 8 mg bid.
Child: 2-5 yr 1.3 mg (10 drops) bid; 6-11 yr 2 mg bid; ≥12 yr 4 mg bid.
Oral
Mucolytic
Special Precautions Patient w/ history of peptic ulceration, asthma. Severe hepatic or renal impairment.
Adverse Drug Angioedema, rash, urticaria, pruritus, bronchospasm, nausea, vomiting, dizziness,
Reactions sweating, headache, diarrhoea, upper abdominal pain, transient increase in serum
aminotransferase values.
Mechanism of Description: Bromhexine enhances mucus transport by reducing mucus viscosity and by
Action activating the ciliated epithelium (mucociliary clearance).
Pharmacokinetics:
Absorption: Rapidly absorbed from the GI tract. Bioavailability: Approx 20%. Time to peak
plasma concentration: Approx 1 hr.
Distribution: Widely distributed to body tissues. Crosses blood brain-barrier and placenta
(small amounts). Plasma protein binding: >90%.
Metabolism: Extensive hepatic first-pass metabolism.
Excretion: Via urine (approx 85-90%, mainly as metabolites). Terminal elimination half-life:
13-40 hr.
ATC Classification R05CB02 - bromhexine ; Belongs to the class of mucolytics. Used in the treatment of wet
cough.
Senna
Indications / Uses
Used as a natural laxative for the relief of constipation.
Contraindications
Special Precautions
Special Precautions
Special Precautions
Do not use laxative products when abdominal pain, nausea or vomiting is present
unless directed by the doctor. Laxative products should not be used for a period longer
than 1 week unless directed by the doctor. Long term use of stimulant laxatives should
be avoided as it may lead to impaired function of the intestine, dependence of laxatives,
dehydration and electrolyte imbalance. Prolonged excessive use or misuse of these
products may also result in the development of atonic colon. Rectal bleeding or failure
to have a bowel movement after use of a laxative may indicate a serious condition.
Discontinue use and consult the doctor. Note: For patients on a sodium-restricted diet,
there is a very small amount of sodium in the sennosides.
In case of allergic symptoms, stop treatment and consult the doctor. Call the doctor if
constipation does not improve or if it gets worse.
Pregnancy & lactation: If pregnant or nursing, seek the advice of the doctor before
using the product.
Use In Pregnancy & Lactation
If pregnant or nursing, seek the advice of the doctor before using the product.
Adverse Reactions
All medicines can have side effects. Sometimes they are serious, most of the time they
are not. The patient may need to consult the doctor or pharmacist, if he/she notices any
side effects.
The side effects listed as follows are classified by body system according to their
incidence (common or uncommon). Common side effects have an incidence of ≥1%
and uncommon effects have an incidence of <1%.
Gastrointestinal Disorders: Common: Abdominal pain. Uncommon: Feces discolored,
nausea, rectal hemorrhage, vomiting, diarrhea.
Immune System Disorders: Uncommon: Urticaria, anaphylactic or anaphylactoid
reaction, hypersensitivity.
Renal and Urinary Disorders: Uncommon: Chromaturia.
Reproductive System and Breast Disorders: Uncommon: Breast milk discoloration.
Skin and Subcutaneous Tissue Disorders: Uncommon: Erythematous rash, maculo-
papular rash, perianal irritation, pruritus.
Due to the presence of chrysophanic acid in natural senna, sennoside-containing
laxatives may cause discoloration of breast milk, urine, or feces. There is no pathologic
significance to this discoloration. Urine discoloration (chromaturia), if present, may
interfere with the interpretation of laboratory tests.
Reversible pigmentation of the colon, i.e., melanosis coli, may also result from
prolonged use of senna containing preparations.
Dosage
Take preferably at bedtime. Bowel movement generally occurs within 6 to 12 hours following
ingestion. The correct dose of the sennosides-containing laxatives is the smallest required to
produce a comfortable bowel movement and varies between individuals.
Dosage can be adjusted to meet individual requirements. If comfortable bowel movement is not
achieved by the second day, increase recommended dose by one tablet (up to maximum
dosage) or decrease until the most effective dose is established or as prescribed by the doctor.
Missed Dose: Follow dosing instructions. If a dose is missed, take it as soon as remembered. If
it is near the next dose, skip the missed dose and resume the usual dosing schedule. Do not
double-up the dose to catch-up.
Overdosage
Signs & Symptoms: The major symptoms of overdose/abuse with any stimulant
laxative including those containing senna are griping pain and severe diarrhea, leading
to excessive water loss (dehydration) and possible electrolyte imbalance.
Treatment should be supportive with generous amounts of fluid. Electrolytes, especially
potassium, should be monitored. This is especially important in the elderly.
In case of accidental overdose, please consult the doctor.
Drug Interactions
There are no known drug interactions with sennosides.
Dosage / Overdosage
Contraindications
Special Precautions
Side Effects / Adverse Reactions
Drug Interactions
Presentation / Storage
Manufacturer Info
Presentation / Storage
Description
vegetable laxatives derived from the senna plant that has been standardized for predictable
results. The active components responsible for its laxative effect in STANDARDIZED SENNA
Glycosides are converted into aglycones through the enzymatic action of colonic bacteria, which
induce colonic peristalsis and bowel evacuation. This action is virtually colon-specific, since
these compounds have little or no action in the stomach and small intestine.
Senokot: Each tablet contains 187 mg Standardized Senna Concentrate equivalent to 8.6 mg
Sennosides A and B.
Senokot Forte: Each tablet contains 374 mg Standardized Senna Concentrate equivalent to
Presentation / Packing
Senokot: Tab 187 mg x 100's, 200's. Senokot Forte: Forte tab 374 mg x 100's.
Storage
Dextromethorpan
Indications Cough suppressant.
Contraindications Patients at risk of developing resp failure. Concomitant or w/in 14 days of MAOI or SSRI
therapy.
Special Precautions Patient w/ bronchitis, emphysema, asthma or other conditions where chronic or persistent
cough occurs, history of drug abuse. Hepatic impairment. Childn. Pregnancy and lactation.
Category C: Either studies in animals have revealed adverse effects on the foetus
(teratogenic or embryocidal or other) and there are no controlled studies in women or
studies in women and animals are not available. Drugs should be given only if the potential
benefit justifies the potential risk to the foetus.
Patient Counselling This drug can cause cognitive function impairment, if affected, do not drive or operate
machinery.
Lab Interference False positive phencyclidine, opioids and heroin urine drug screen.
ATC Classification R05DA09 - dextromethorphan ; Belongs to the class of opium alkaloids and derivatives.
Used as cough suppressant.
Combantrin
Category C: Either studies in animals have revealed adverse effects on the foetus
(teratogenic or embryocidal or other) and there are no controlled studies in women or
studies in women and animals are not available. Drugs should be given only if the
potential benefit justifies the potential risk to the foetus.
MIMS Class
Anthelmintics
ATC Classification
P02CC01 - pyrantel ; Belongs to the class of tetrahydropyrimidine derivative agents.
Used as antinematodal.
Regulatory Classification
Non-Rx
Presentation / Packing
Form Packing/Price
Combantrin oral susp 125
10 mL x 1's (P153.50/bottle)
mg/5 mL
Combantrin tab 125 mg 100's (P2852.25/pack)
Indications Listed in Dosage.
Oral
Trichinosis
Oral
Necatoriasis
Adult: 10 mg/kg daily for 3-4 days or 20 mg/kg daily for 2 days.
Oral
Enterobiasis
Adult: 10 mg/kg repeated once after 2-4 wk. Max dose: 1 g/dose.
Oral
Ascariasis
Adult: 5 mg/kg as a single dose. Max: 1 g/dose. For mass treatment programmes: 2.5
mg/kg as a single dose given 3-4 times a yr.
Special Precautions Liver dysfunction, anaemia or severe malnutrition. Treat members in close contact with the
patient.
Adverse Drug Anorexia, nausea, vomiting, abdominal cramps, drowsiness, insomnia, diarrhoea,
Reactions tenesmus, SGOT elevations, headache, dizziness, rash.
Pregnancy Category ROUTE(S) : PO
(US FDA)
Category C: Either studies in animals have revealed adverse effects on the foetus
(teratogenic or embryocidal or other) and there are no controlled studies in women or
studies in women and animals are not available. Drugs should be given only if the potential
benefit justifies the potential risk to the foetus.
Bonamine
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but
there are no controlled studies in pregnant women or animal-reproduction studies have
shown an adverse effect (other than a decrease in fertility) that was not confirmed in
controlled studies in women in the 1sttrimester (and there is no evidence of a risk in later
trimesters).
MIMS Class
Antiemetics
ATC Classification
R06AE05 - meclozine ; Belongs to the class of piperazine derivatives used as systemic
antihistamines.
Regulatory Classification
Non-Rx
Presentation / Packing
Form Photo Packing/Price
Bonamine chewable tab
120's (P1230.00/pack)
12.5 mg